OES HYSTEROFIBERSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one OES HYSTEROFIBERSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 5 models of OES HYSTEROFIBERSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2019 and Aug 13, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (24 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
OES HYSTEROFIBERSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 25, 2023Open, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0337-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 25, 2023Open, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0335-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported OES HYSTEROFIBERSCOPE problems
Device problems
- Microbial Contamination of Device24
- Failure to Clean Adequately8
- Corroded5
- Device Reprocessing Problem5
- Degraded3
- Detachment of Device or Device Component2
- Material Deformation2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient2
OES HYSTEROFIBERSCOPE models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE XPHYSTEROSCOPE (AND ACCESSORIES)1 recall34 reports
- OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE 1THYSTEROSCOPE (AND ACCESSORIES)1 recall0 reports
- OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE XPHYSTEROSCOPE (AND ACCESSORIES)18 reports
- OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE XPHYSTEROSCOPE (AND ACCESSORIES)3 reports
- OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE 1THYSTEROSCOPE (AND ACCESSORIES)1 report
Recent OES HYSTEROFIBERSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230461 ↗MalfunctionAug 6, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168459 ↗MalfunctionAug 3, 2026Corroded; Failure to Clean Adequately
The customer returned the Hysterofiberscope, which is an Olympus asset with no reported complaint. During the evaluation of the device, the Service Repair Technician observed corrosion on the distal end and a sticky body control unit. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118732 ↗MalfunctionJul 9, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE HYSTEROFIBERSCOPE EXHIBITED STICKINESS ON THE CONTROL SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25773243 ↗MalfunctionMay 29, 2026Corroded
THE CUSTOMER RETURNED THE HYSTEROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OLYMPUS SERVICE CENTER TECHNICIAN INDICATED THAT A CORRODED DISTAL END WAS FOUND. IT WAS DETERMINED THAT THE DISTAL END NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331787 ↗MalfunctionApr 29, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTERO FIBERSCOPE EXHIBITED CORROSION ON THE ADHESIVE OF THE BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029060 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE OES HYSTEROFIBERSCOPE EXHIBITED THAT THE INSERTION TUBE SURFACE COMES OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874317 ↗MalfunctionApr 10, 2026Contamination; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROFIBERSCOPE UNIVERSAL CORD WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845460 ↗MalfunctionApr 3, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROFIBERSCOPE BENDING SECTION COVER RUBBER HAD A CHIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781075 ↗MalfunctionApr 1, 2026Corroded; Degraded
IT WAS OBSERVED THAT DURING THE EVALUATION, THE OES HYSTEROFIBERSCOPE FORCEPS CHANNEL PORT HAS CORROSION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761513 ↗MalfunctionMar 3, 2026Residue After Decontamination
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499320 ↗MalfunctionNov 17, 2025Collapse; Collapse
IT WAS REPORTED THE SUBJECT DEVICE DISTAL END "EXPLODED". THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575855 ↗MalfunctionOct 16, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROFIBERSCOPE EXHIBITED A BROKEN FORCEPS PORT COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312341 ↗MalfunctionAug 18, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE FORCEPS CHANNEL PORT WAS CORRODED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22833510 ↗MalfunctionAug 18, 2025Degraded; Material Discolored; Degraded; Material Discolored
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SCOPE EXHIBITED CORROSION ON THE DISTAL END AND FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22826014 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page